Gemcitabine Hydrochloride for Injection 0.2g / High Quality

• Customization: Available
• Packaging From: 1 Vial /Box
• Packaging: Customization
• Model NO.: Powder for injection
• Dosage: Ready
• Certified: GMP
• Transport Package: Shipping
• Specification: 0.2g
• Trademark: Customization
• Origin: China

Product Description

Value-added services:
 1) Packaging design by our team
 2) Registration service by our team
 3) Registration dossier available by our team
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Gemcitabine Hydrochloride for Injection 0.2g

Composition:

Each vial contains:

• Gemcitabine Hydrochloride 200mg (equivalent to 200mg Gemcitabine)

Description:

Gemcitabine is a nucleoside analog that inhibits DNA synthesis, leading to cell cycle arrest and apoptosis (programmed cell death) in tumor cells. It has broad-spectrum activity against various cancers.

Indications:

Gemcitabine is indicated for the treatment of:

• Non-small cell lung cancer (NSCLC) (as monotherapy or in combination with cisplatin)
• Pancreatic cancer (first-line treatment for locally advanced or metastatic cases)
• Bladder cancer (in combination with cisplatin)
• Breast cancer (in combination with paclitaxel for metastatic cases)
• Ovarian cancer (in combination with carboplatin)

Dosage & Administration:

Recommended Dosage (Adults Only):

Non-Small Cell Lung Cancer (NSCLC):

• Monotherapy: 1000 mg/m² IV on Days 1, 8, and 15 of a 28-day cycle
• Combination with Cisplatin: 1250 mg/m² IV on Days 1 and 8 of a 21-day cycle

Pancreatic Cancer:

• 1000 mg/m² IV once weekly for 7 weeks, followed by 1 week of rest, then continue with a 28-day cycle (Days 1, 8, and 15)

Bladder Cancer:

• Combination with Cisplatin: 1000 mg/m² IV on Days 1, 8, and 15 of a 28-day cycle

Breast Cancer:

• Combination with Paclitaxel: 1250 mg/m² IV on Days 1 and 8 of a 21-day cycle

Ovarian Cancer:

• Combination with Carboplatin: 1000 mg/m² IV on Days 1 and 8 of a 21-day cycle

Administration:

• IV Infusion over 30 minutes (do not administer as a rapid bolus)
• Reconstitution:
  • Add 5mL of sterile 0.9% sodium chloride injection to the 200mg vial
  • Shake gently until completely dissolved
  • Use within 24 hours after reconstitution (store at 2-8°C if not used immediately)

Dose Adjustments:

• Hepatic Impairment: Use with caution-monitor liver function
• Renal Impairment: No specific adjustments, but monitor for toxicity
• Hematologic Toxicity: Reduce or delay dosing based on neutropenia or thrombocytopenia

Contraindications:

• Hypersensitivity to Gemcitabine or excipients
• Severe bone marrow suppression
• Pregnancy & breastfeeding (Category D - may cause fetal harm)

Precautions:

• Myelosuppression: Monitor WBC, platelets, and hemoglobin levels
• Hepatotoxicity: Monitor ALT, AST, and bilirubin
• Renal toxicity: Risk of hemolytic uremic syndrome (HUS)
• Pulmonary toxicity: Risk of interstitial lung disease (ILD) or pulmonary edema
• Capillary Leak Syndrome (CLS): Rare but serious risk

Adverse Reactions:

• Common: Fatigue, nausea, vomiting, fever, rash, flu-like symptoms
• Serious: Bone marrow suppression, liver enzyme elevation, kidney dysfunction, lung toxicity

Drug Interactions:

• Cisplatin & Carboplatin: Increased hematologic toxicity
• Paclitaxel: Enhanced side effects-administer Paclitaxel before Gemcitabine
• Radiotherapy: Increased risk of radiation recall syndrome

Overdose & Management:

• Symptoms: Severe neutropenia, thrombocytopenia, hepatotoxicity
• Treatment: Supportive care, transfusions if necessary, and infection prevention

Storage Conditions:

• Store below 25°C, in a dry place
• Use within 24 hours after reconstitution (keep at 2-8°C)